About this trial
This study will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (\<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years as of the screening date;
Patients with non-cardioembolic ischemic stroke or TIA within 3 months prior to the screening date;
Prescribed Evolocumab at physician's discretion;
Signed informed consent.
Disqualifiers
Intracranial hemorrhagic diseases: such as cerebral hemorrhage, subarachnoid hemorrhage, etc.;
Patients confirmed by baseline head CT or MRI to have hemorrhage or other pathological brain diseases, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis);
Silent cerebral infarction without signs and symptoms;
Participation in a clinical trial of another drug or device in the past 3 months or ongoing at the time of the screening date;
Trial design
Parallel
Treatments tested in this trial
the Intelligent Lipid Management Decision-support System
DeviceDoctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment
To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (\<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post.
Secondary outcomes
Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months).
To investigate the LDL-C percentage decrease from baseline in patients with ischemic stroke or TIA using Evolocumab at 3 months and 12 months.
Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) within 12 months post-intervention.
Duration (in months) of maintaining LDL-C levels within the target range (\<1.8 mmol/L) among patients receiving Evolocumab treatment, within 12 months post-intervention.
Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 3 months with Evolocumab treatment
To investigate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients achieving target LDL-C levels at 3 months under Evolocumab treatment with ischemic stroke or TIA in China
Frequency of subcutaneous Evolocumab injections at 3-month follow-up
Frequency of subcutaneous Evolocumab injections at 3-month follow-up as a measure of treatment persistence in ischemic stroke/TIA patients
Sponsors and contacts
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